OncoMatch/Clinical Trials/NCT06746688
A First-in-human, Clinical Trial Assessing the Safety of ES2B-C001-S01 With or Without [Adjuvant] in Patients With HER2 Expressing Metastatic Breast Cancer.
Is NCT06746688 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ES2B-C001 for breast cancer.
Treatment: ES2B-C001 — The trial is a first-in-human, phase I, open-label, dose-escalating trial to assess the safety and tolerability of ES2B-C001 combined with or without \[adjuvant\], in patients with human epidermal growth factor receptor 2 (HER2) expressing metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Disease stage
Metastatic disease required
Diagnosis of HER2-positive metastatic or locally advanced inoperable breast cancer (MBC)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: intravenous chemotherapy
Exception: MBC maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) at the discretion of the treating physician is allowed
Any planned intravenous chemotherapy regimens or check point inhibitors, or previous therapy with those agents during the past 1 month and the patients are not neutropenic. For MBC maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) at the discretion of the treating physician is allowed.
Cannot have received: checkpoint inhibitor
Exception: MBC maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) at the discretion of the treating physician is allowed
Any planned intravenous chemotherapy regimens or check point inhibitors, or previous therapy with those agents during the past 1 month and the patients are not neutropenic. For MBC maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) at the discretion of the treating physician is allowed.
Lab requirements
Blood counts
adequate bone marrow function without clinically significant laboratory parameters as judged by the investigator
Kidney function
adequate kidney function without clinically significant laboratory parameters as judged by the investigator
Liver function
adequate liver function without clinically significant laboratory parameters as judged by the investigator
Cardiac function
adequate heart function without clinically significant laboratory parameters as judged by the investigator; 12-lead ECG without clinically significant abnormalities and no LBBB, QRS duration >140ms, or evidence of prior infarction; Echocardiography with LVEF ≥55%; Previous documented coronary artery disease or congestive heart failure (>NYHA II) excluded; Uncontrolled hypertension excluded
Patients have adequate bone marrow, kidney, liver, heart, and lung function without clinically significant laboratory parameters as judged by the investigator. 12-lead ECG without clinically significant abnormalities and no LBBB, QRS duration >140ms, or evidence of prior infarction. Echocardiography with LVEF <55% [excluded]. Previous documented coronary artery disease or congestive heart failure (>NYHA II) [excluded]. Uncontrolled hypertension [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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